Technician I, Purification

Role Summary

Role: Technician I, Purification. This position is under direct supervision of the Group Leader. This experienced position is responsible for the manufacture of plasm products through protein separation and other tasks involving Ultrafiltration, Chromatography, and Nanofiltration.

Responsibilities

• Cleans and sanitizes equipment before and after use.
• Responsible for production operations.
• Makes and verifies connections on flow panels.
• Performs pH and conductivity measurements.
• Performs chemical and buffer additions.
• Operation of Ultrafiltration system.
• Initiates product processes on the Process Automated System (PAS).
• Column chromatography using up to 80cm columns.
• Takes and prepares product samples.
• Orders and maintains raw material inventories.
• Complete batch records.
• Assists Group Leaders in training of other tech positions.

Qualifications

• GMP experience required.
• Ability to follow the cGMPs and procedures with great attention to detail.
• Compliance requirements: The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.

Education

• Bachelor’s degree or equivalent experience.